Optimization and Characterization of Iron Sucrose Colloidal Formulation with Enhanced Stability and Reduced Labile Iron Content

Background Iron sucrose is a cornerstone therapy for iron deficiency anemia, particularly in chronic kidney disease. However, marketed formulations can contain labile iron, which catalyzes reactive oxygen species generation, contributing to oxidative stress and infusion reactions. This study aimed to develop an optimized iron sucrose colloidal solution with improved physicochemical stability and a reduced fraction of labile iron.Methods A systematic formulation optimization was conducted, investigating critical process parameters order of addition, pH, sterilization method, and oxygen control via nitrogen sparging. The optimized formulation was characterized for description, pH, particle size as determined by dynamic light scattering, DLS , zeta potential, iron assay using FAAS , and labile iron content via a ferene SPE assay . Stability was assessed under accelerated 40°C 75 RH and long term 25°C 60 RH conditions for two months.Results The optimal process involved adjusting Water for Injection pH to 10.8 before API addition, aseptic filtration, and stringent oxygen control 2 ppm . The optimized formulation exhibited properties comparable to the reference listed drug Venofer particle size Z avg 12 nm, PDI 0.180 , zeta potential 26.4 mV , and assay 98.9 . Crucially, the labile iron content was significantly reduced to 0.22 compared to 0.35 for Venofer a 37 reduction . Stability studies confirmed the formulations robustness, with all critical quality attributes remaining within specification over the study period.Conclusion This study successfully developed a stable iron sucrose formulation with a significantly lower labile iron content. The rigorous control of oxygen during manufacturing was identified as a key factor in minimizing oxidative degradation. This optimized product has the potential to offer an improved safety profile for patients requiring intravenous iron therapy. Nitin Suthar | Narendra Singh Solanki | Deepak Singodia | Jayesh Gadhiya "Optimization and Characterization of Iron Sucrose Colloidal Formulation with Enhanced Stability and Reduced Labile Iron Content" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-9 | Issue-5 , October 2025, URL: https://www.ijtsrd.com/papers/ijtsrd97558.pdf Paper URL: https://www.ijtsrd.com/pharmacy/pharmaceutics/97558/optimization-and-characterization-of-iron-sucrose-colloidal-formulation-with-enhanced-stability-and-reduced-labile-iron-content/nitin-suthar